(132 days)
The JAZZ LOCK is a temporary implant to be used in orthopedic surgery. JAZZ LOCK is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. JAZZ LOCK is designed for a posterior approach. The indications for use include the following applications:
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Spinal trauma surgery: Jazz Lock implants can be used in sublaminar wiring technique;
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Spinal degenerative surgery: Jazz Lock implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.
The JAZZ LOCK consists of the following components and accessories: Titanium alloy Ti6Al4V locking base; PEEK Optima LT1 locking insert; polyester (polyethyleneterephthalate) braid; and stainless steel malleable strip and buckle. The braid is passed through the locking insert and around the pertinent spinal anatomy. The locking insert is compressed as it snaps into the locking base. locking the braid in place. The system also contains device-specific instrumentation used to position and tension the braid and lock the insert to the base.
The provided 510(k) summary for the JAZZ LOCK device focuses on establishing substantial equivalence to a predicate device through bench testing rather than clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, ground truth establishment for patient data, and human reader performance are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance (Summary) |
|---|---|
| Static Construct Strength | "All bench testing confirmed that the product met the necessary specifications and is equivalent to the predicate." |
| Dynamic Construct Strength | "All bench testing confirmed that the product met the necessary specifications and is equivalent to the predicate." |
| Bone Cut Propensity (Static) | "Bench testing also demonstrates that the wider contact area and softer nature of the polyester braid offers at least equivalent performance in regards to the risk of wire damaging the bone." |
| Braid Creep Resistance | "Creep testing of the braid showed adequate resistance to plastic deformation." |
| Biocompatibility | "The biocompatibility of the device has been confirmed in accordance with ISO 10993." |
| Sterilization Validation | "The Company has conducted sterilization and shelf life validation in accordance with recognized industry standards." |
| Shelf Life Validation | "The Company has conducted sterilization and shelf life validation in accordance with recognized industry standards." |
2. Sample Size Used for the Test Set and Data Provenance
Since this involves bench testing of a medical device, not a study on patient data, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not applicable. The "test set" would refer to the physical samples of the JAZZ LOCK device tested. The document does not specify the number of units tested for each bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study is a bench test for mechanical properties and biocompatibility, not a clinical study requiring expert interpretation of patient data. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies.
4. Adjudication Method for the Test Set
This is not applicable for bench testing. Adjudication methods are typically used in clinical studies where there's variability or disagreement among human readers or evaluators of patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study involves human readers evaluating cases, which is not relevant to the reported bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The JAZZ LOCK is a physical implant, not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993 for biocompatibility), and comparison with the mechanical properties and performance of the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical study with patient data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.